FDA approves Ebola treatment for the first time
The FDA approved Regeneron’s Inmazeb, formerly called REGN-EB3, to treat Zaire ebolavirus infection in adult and pediatric patients — the first-ever FDA-approved treatment for Ebola.
Inmazeb is a mixture of three monoclonal antibodies: atoltivimab, maftivimab and odesivimab-ebgn. It was one of two investigational Ebola treatments that proved effective in a groundbreaking randomized control trial conducted during the recent outbreak in eastern Democratic Republic of the Congo.
“Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats — both domestically and abroad — on the basis of science and data,” FDA Commissioner Stephen M. Hahn, MD, said in a press release. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”
According to the FDA, Inmazeb targets the glycoprotein on the surface of Ebola virus, which is what allows the virus to enter a host cell. The three antibodies that make up Inmazeb bind to this glycoprotein simultaneously and block attachment and entry of the virus.
Inmazeb, which previously received orphan drug designation by the FDA, was evaluated for safety and efficacy in the PALM trial, a multicenter, open-label, randomized controlled trial of adults with confirmed Zaire ebolavirus infection that was led by the NIH and DRC researchers. During the trial, 154 patients received Inmazeb intravenously as a single infusion and 168 patients received an investigational control. According to the FDA, of the 154 patients who received Inmazeb, 33.8% died after 28 days compared with 51% of the 153 patients in the control arm. An additional 228 patients received Inmazeb as part of an expanded access program.
The FDA outlined common symptoms experienced while using Inmazeb, including fever, chills, tachycardia, tachypnea and vomiting although it said these are also symptoms of Ebola virus infection.
“Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “The urgent need for advanced therapies to combat this infectious disease is clear, and today’s action is a significant step forward in that effort.”
Last December, the FDA approved an Ebola vaccine for the first time, Merck’s Ervebo.